COSTA MESA, Calif., Nov. 16 /PRNewswire/ -- Viratek, Inc. (AMEX: VRA) said today it continued to significantly invest in increased research and development programs in the third quarter of 1993, including investment behind Phase III clinical trials of its proprietary antiviral ribavirin (Virazole) against chronic active hepatitis C.
Ribavirin capsules are currently being evaluated investigationally in the treatment of chronic active hepatitis C in three Phase III trials in the United States and Europe. The company is conducting a 58-patient, double-blind, placebo-controlled multicenter trial in the U.S. and a 110-patient multicenter, double-blind, placebo-controlled trial in Europe. A third double-blind, 56-patient placebo-controlled trial is being conducted by the National Institutes of Health Liver Diseases Section.
In an abstract published in Hepatology (Vol. 18, No. 4, Pt. 2, 1993) NIH investigators said initial, preliminary results of their trial showed that in 16 patients "... prolonged ribavirin therapy was associated with significant improvement in serum ALT levels (despite unchanged serum HCV RNA levels) and in hepatic lobular necrosis." Full trial results await publication. Ribavirin is not currently indicated for treatment of chronic active hepatitis C in the U.S., although if trials prove successful, application will made to the U.S. Food and Drug Administration for commercialization.
It is estimated that 1.8 million Americans are infected with hepatitis C (i.e., have antibodies to hepatitis C), with 150,000 new infections annually. There are an estimated 275,000 cases of chronic active hepatitis C cases in the U.S. at present. Hepatitis C is a slowly progressive liver disease that often leads to inflammation of the liver, cirrhosis or liver cancer.
Third quarter 1993 revenues totaled $2 million, with a net income of $249,000, or 2 cents per share. Research and development spending was $1.4 million in the third quarter.
Viratek derives its revenues from sales in more than 40 countries by SPI Pharmaceuticals of Virazole (ribavirin), on which it holds the patent. Third quarter Virazole sales by SPI benefited from continued medical and patient acceptance, including in Mexico, where sales were up 70 percent in the first nine months of 1993. SPI's Mexican subsidiary recently launched Virazole cream for herpes zoster and herpes genitalis and is now the leading antiviral on the market in Mexico.
Viratek recently announced it has initiated a new pharmaceutical discovery program to develop therapeutic drugs that selectively block the expression of specific genes that cause disease. The program, based on oligonucleotide antisense technology, is targeting research against cancer, viral and skin disorders. Also, Viratek is developing anti- cancer and immune-stimulatory compounds and is researching potential new biomedical research products.
At the end of the third quarter of 1993, Viratek had $33 million in cash and receivables from affiliates.
Viratek is an operating subsidiary of ICN Pharmaceuticals, Inc. (NYSE: ICN).
VIRATEK, INC.
Summary Financial Information
For the three and nine months ended Sept. 30, 1993 and 1992
(000's omitted, except per share amounts)
(unaudited)
Periods ended Three months Nine months
Sept. 30, 1993 1992 1993 1992
Total revenues $ 2,048 $ 1,948 $ 4,032 $ 4,206
Research & Development 1,390 922 3,689 1,307
Net Income (loss) $ 249 $ 679 $ (573) $ 2,219
Per share information:
Net income (loss) $ 0.02 $ 0.05 $ (0.04) $ 0.15
Shares used in per share
computation 16,534 14,478 15,752 14,533
-0- 11/16/93
/CONTACT: Jack Sholl for Viratek, 714-545-0100 ext. 3013/
(VRA ICN)